The FDA recently announced with great fanfare that it will soon exempt most drugs for Phase I trials from its cGMP regulations in an effort to streamline the development process. However, under the law, the agency is still responsible for ensuring the safety of those products. In fact, on the same day the FDA made its announcement, it issued guidance on new manufacturing requirements that apply only to the Phase I drugs that are exempted from the regulatory cGMPs.

That means you will have to have two sets of cGMPs — one for investigational drugs and another for Phase II, III and approved drugs. The penalties for not following the new Phase I requirements are severe. The FDA can suspend your trial, terminate your IND or even confiscate the product.

You have a lot to learn, and the deadline for compliance is coming up fast …

GMP expert Daniel Kuebbing will walk you through the new guidance and give practical, on-the-ground advice on complying with it.

Daniel Kuebbing is the director of GMP Training and Biomanufacturing Program, University of Maryland Biotechnology Institute. He received a bachelor’s degree in Biology from Thomas More College and a Ph.D., in Biochemistry from the University of Miami. He has more than 28 years’ experience in biotechnology settings. He has worked in academia and the biotech industry. During the past 20 years, he has been responsible for overseeing design, construction, equipment selection, validation and management of biotechnology R&D and QC laboratories, as well as GMP production facilities both at operating companies and as a consultant. He was one of the founding scientists at Genetic Therapy, Inc., and was responsible for the production and QC of clinical-grade retroviral vectors for clinical trials in gene therapy.